WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE

K011598 · Irvine Scientific Sales Co., Inc. · MTW · Jun 13, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K011598
• Device Name: WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MTW · Obstetrics/Gynecology
• Decision Date: Jun 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6170
• Device Class: Class 2

Intended Use

Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures.

Device Story

Water for Assisted Reproductive Technologies (A.R.T.) Use is a high-purity, non-pyrogenic water medium; used in A.R.T. laboratory settings by embryologists/technicians; supports fertilization and growth of human gametes and embryos; quality verified via mouse embryo assay and USP 24 testing; ensures absence of toxic components; provides a standardized environment for laboratory procedures.

Clinical Evidence

No clinical data. Bench testing only: product is assayed by mouse embryo assay to ensure support for embryonic growth and absence of toxic components; meets USP 24 testing requirements.

Technological Characteristics

Highly purified water, USP WFI (Water for Injection) grade. Non-pyrogenic. No electronic or software components.

Indications for Use

Indicated for use in assisted reproductive technology (A.R.T.) laboratory procedures requiring high-purity, non-pyrogenic water for the fertilization and growth of human gametes and embryos.

Regulatory Classification

Identification

Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Predicate Devices

• Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Submission Summary (Full Text)

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# JUN 1 3 2001

K011598
May 9, 2001
Page 1 of 2

## 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

Irvine Scientific Sales Co., Inc. Submitted by: 2511 Daimler Street Santa Ana, CA 92705-5588

> Telephone: [phone] Facsimile: [phone]

Contact: Wendell Lee, Pharm. D.

Water for Assisted Reproductive Technologies

Water for Assisted Reproductive Technologies

Date Submitted: May 9, 2001

### Device Identification:

Trade Name:

(A.R.T.) Use

Common Name:

(A.R.T.) Use

Classification Name:Reproductive Media (21 CFR 884.6180)

### Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

#### Description:

Water for Assisted Reproductive Technologies (A.R.T.) Use is a water intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.

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Mav 9. 2001

K011598
page 2 of 2

#### Intended Use:

Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures.

### Technological Characteristics:

Water for Assisted Reproductive Technologies (A.R.T.) Use is highly purified water of USP WFI grade.

#### Performance Data:

Water for Assisted Reproductive Technologies (A.R.T.) Use is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will support embryonic growth and that no toxic components are present. The equivalent of Water for Assisted Reproductive Technologies (A.R.T.) Use has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for the fertilization and growth of human gametes and embryos.

#### Additional Information:

Mouse embryo, and USP 24 testing will be performed as a condition of release for this product. Results of all release assays performed will be indicated on the labeling and reported on a lot-specific certificate of analysis.

#### Conclusion:

The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Water for Assisted Reproductive Technologies (A.R.T.) Use is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N 0335 in addition to showing substantial equivalence to other 510(k) cleared Irvine Scientific products.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The bird symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2001

Wendell Lee, Pharm. D. Vice President Quality Systems and Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K011598

Water for Assisted Reproductive Technologies (A.R.T.) Use Dated: May 9, 2001 Received: May 24, 2001 Regulatory Class: II 21 CFR §884.6170/Procode: 85 MTW

Dear Dr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmadsmamain.html".

Sincerely yours.

Nancy Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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Irvine Scientific

#### INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number: KO11598

Device Name: Water For Assisted Reproductive Technologies (A.R.T.) Use

Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in assisted reproductive technology procedures.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
**(Per 21 CFR 801.109)**

David L. Hynson

Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number